In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book, and that the Federal Circuit subsequently stayed that delisting order on January 22, 2025 following a
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted for approximately half of U.S. healthcare medicine spending in the past few years. While biosimilars have offered
In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book. Following a request from Teva for an en banc rehearing, the Federal Circuit stayed the delisting order on January 22
Since the America Invents Act (“AIA”) established a new venue for hearing patent disputes, the Patent Trial and Appeal Board (“PTAB”), much ink has been spilled regarding the impacts of this forum on patent litigation and the overall intellectual property strategies employed by both patentees and challengers. The Promoting and Respecting Economically Vital American Innovation Leadership
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. The Federal Circuit affirmed the district court’s decision that Teva’s patents were improperly listed and must be
On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins.[1] According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory automation to rapidly design and optimize novel miniproteins with ideal drug-like properties.”[2] The end goal of this collaboration is likely biologic products
The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent infringement in response to Amneal’s ANDA filing seeking to make and sell a generic version of ProAir HFA (albuterol sulfate)
As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified Patent Court (UPC) first decision – invalidating EP Patent No. 3,666,797 B1 – and provided a summary of that case. This analysis will focus
On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi (collectively “defendants”) (DNJ No. 23-cv-22485). The plaintiffs allege that the defendants infringe or intend to infringe fifteen patents related to the biologic rituximab
Artificial Intelligence (AI) has long been associated with science fiction movies about dystopian futures, leading to fear among the general public about its potential impact. This is especially the case today for those in academia who have graded countless papers written by ChatGPT. However, the truth is far from what we see in the movies.